Prescription bottle cap capable of administering opioid overdose reversal agent

ABSTRACT

An apparatus for delivering a therapeutic agent may be associated with a cap for a bottle that contains a prescription for a drug to which the therapeutic agent corresponds. When the prescription bottle contains an opioid, the therapeutic agent may comprise a substance that counteracts the effects of the opioid. The apparatus may include a nozzle that facilitates nasal administration of the therapeutic agent. The apparatus may be capable of attaching to a cap for a prescription bottle, or the apparatus may have a configuration that enables it to serve as the cap for the prescription bottle.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/993,449, filed on Mar. 12, 2019, and titled PRESCRIPTION BOTTLE CAPCAPABLE OF ADMINISTERING OPIOID OVERDOSE REVERSAL AGENT (“the '449application”), now U.S. Pat. No. 10,933,204, issued Mar. 2, 2021 whichclaims priority to the Jun. 1, 2017 filing date of U.S. ProvisionalPatent Application No. 62/513,768, titled NASAL SPRAY DISPENSER CAP(“the '768 Provisional Application”). The entire disclosures of the '449application and the '768 Provisional Application are hereby incorporatedherein.

TECHNICAL FIELD

This disclosure relates generally to prescription bottles and, morespecifically, to caps for prescription bottles. More specifically, thisdisclosure relates to devices that are capable of being used withprescription bottle caps to contain and deliver therapeutic agents,including emergency opioid overdose reversal agents, to an individual inconnection with a drug that has been prescribed to the individual. Sucha device may include features that enable nasal delivery of therapeuticagents. Methods for providing an individual with a prescription are alsodisclosed.

RELATED ART

Due to their effectiveness in treating pain, physicians and otherlicensed healthcare professionals have commonly prescribed opioids usedto their patients. While the benefits of opioids have led to theirwidespread use, they are also highly addictive, and can be dangerous.Oftentimes, a healthcare professional may prescribe an opioid to apatient without realizing the patient suffers from an opioid addiction.A pharmacist may then fill the prescription without any suspicion thatthe patient suffers from an addition.

While the risks that an individual who suffers from an opioid additionwill overdose on opioids are greater than the risks associated withpatients who benefit from but are not dependent on opioids, there isalways a risk that a recipient of opioids will overdose. That risk hasbecome so significant in recent years that fatalities from opioidoverdoses have recently reached epidemic proportions.

Although opioid overdoses can be effectively treated with opioidoverdose reversal agents, such as naloxone, access to effectivetreatments is limited primarily to emergency medical personnel. Becauseopioid overdoses are often unexpected, and because of the limitedavailability of countermeasures, unnecessary deaths from opioidoverdoses are frequent.

SUMMARY

Apparatuses, systems, and methods for administering therapeutic agentsor others Apparatuses, systems, and methods for administeringtherapeutic agents or other substances that correspond to prescribeddrugs are disclosed. These include apparatuses, systems, and methods fortreating, or reversing the effects of, opioid overdoses.

An apparatus that enables reversal of the effects of an opioid overdosemay have a configuration that enables it to be secured to a cap for aprescription bottle, or the apparatus may comprise a cap for aprescription bottle. Accordingly, such an apparatus is referred toherein as a “cap.” In addition to including features that enable the capto contain the contents of the prescription bottle (e.g., an opioid,etc.) within the interior of the prescription bottle, the cap includes adelivery element capable of storing and selectively administering asubstance (e.g., a therapeutic agent, such as an opioid overdosereversal agent, etc.) to an individual.

The delivery element of a cap according to this disclosure may becapable of delivering a substance for nasal administration to anindividual. Such a delivery element may include a reservoir, a pump, anda nozzle. The reservoir may store the substance. The pump may be capableof forcing the substance from the reservoir, through the nozzle, and outof the nozzle. In some embodiments, the pump may include an actuatorthat enables an individual to operate the delivery element (e.g., theactuator may be depressible, such as by a finger or thumb of anindividual, etc.). The nozzle may be capable of delivering the substanceto an individual in a desired manner (e.g., by creating a fine mist froma liquid substance for nasal administration, by creating a puff of asolid substance for nasal administration, etc.). The nozzle of such adelivery element may be movable between a stored orientation and adeployed orientation. While in the stored orientation, the nozzle may becompactly assembled with a remainder of the delivery element. The storedorientation of the nozzle may prevent or preclude use (e.g., depression,etc.) of the actuator of the pump. In its deployed orientation, thenozzle may protrude from the remainder of the delivery element in amanner that facilitates its use in administering the substance to anindividual.

In another aspect, drug delivery systems are disclosed. A drug deliverysystem may include a cap according to this disclosure, as well as aprescription bottle. The prescription bottle may contain a quantity of afirst substance, while the cap may contain a quantity of a secondsubstance. The second substance may correspond to the first substance.As an example, the second substance may complement the first substance.As another example, the second substance may counteract a negativeeffect (e.g., an adverse condition, etc.) caused by the first substance.In embodiments where the first substance is an opioid (e.g., aprescribed opioid, etc.) and the second substance is an opioid overdosereversal agent, a drug delivery system according to this disclosure mayfacilitate a prompt, effective response to an overdose of the opioid.

According to another aspect, methods for providing prescription drugs,including, but not limited to opioids, to an individual are disclosed.Such a method includes filling a prescription bottle with the prescribeddrug and enclosing the prescribed drug within an interior of theprescription bottle with a cap that contains and that is capable ofdelivering, or administering, a substance that corresponds to theprescribed drug.

A method for administering a substance to an individual to supplement orcounteract another substance consumed by the individual includesdelivering the substance from a cap of a prescription bottle thatcontained the consumed substance.

Other aspects of the disclosed subject matter, as well as features andadvantages of various aspects of the disclosed subject matter, willbecome apparent to those of ordinary skill in the art throughconsideration of the ensuing description, the accompanying drawings, andthe appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a frontal perspective view of an embodiment of a prescriptionbottle cap, showing a nozzle of a delivery element in a deployedorientation, in which the nozzle protrudes or extends from a remainderof the prescription bottle cap, rendering an actuator of a pump of thedelivery element accessible for operation of the delivery element;

FIG. 2 is a front view of the prescription bottle cap shown in FIG. 1;

FIG. 3 is a left side view of the prescription bottle cap shown in FIG.1;

FIG. 4 is a top view of the prescription bottle cap shown in FIG. 1;

FIG. 5 is a rear view of the prescription bottle cap shown in FIG. 1;

FIG. 6 is a right side view of the prescription bottle cap shown in FIG.1;

FIG. 7 is a bottom view of the prescription bottle cap shown in FIG. 1;

FIG. 8 is a frontal perspective view of the embodiment of prescriptionbottle cap shown in FIG. 1, with the nozzle of the delivery element in astored orientation over the actuator of the pump of the deliveryelement, restricting access to and use of the actuator;

FIG. 9 is an exploded view of the prescription bottle cap shown in FIG.1;

FIGS. 9A-9C provide enlarged views of various elements of theprescription bottle cap shown in FIG. 9;

FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 8through a centerline of the prescription bottle cap of FIG. 1, includingthe nozzle of the delivery element of the prescription bottle cap;

FIG. 11 is a frontal perspective view of an embodiment of a prescriptionbottle cap, showing a nozzle of a delivery element in a deployedorientation, in which the nozzle protrudes or extends from a remainderof the prescription bottle cap, rendering an actuator of a pump of thedelivery element accessible for operation of the delivery element;

FIG. 12 is a front view of the prescription bottle cap shown in FIG. 11;

FIG. 13 is a left side view of the prescription bottle cap shown in FIG.11;

FIG. 14 is a top view of the prescription bottle cap shown in FIG. 11;

FIG. 15 is a rear view of the prescription bottle cap shown in FIG. 11;

FIG. 16 is a right side view of the prescription bottle cap shown inFIG. 11;

FIG. 17 is a bottom view of the prescription bottle cap shown in FIG.11;

FIG. 18 is a frontal perspective view of the embodiment of prescriptionbottle cap shown in FIG. 11, with the nozzle of the delivery element ina stored orientation over the actuator of the pump of the deliveryelement, restricting access to and use of the actuator;

FIG. 19 is an exploded view of prescription bottle cap shown in FIG. 11;and

FIG. 20 is a cross-sectional view taken along line 10-10 of FIG. 18through a centerline of the prescription bottle cap of FIG. 1, includingthe nozzle of the delivery element of the prescription bottle cap.

DETAILED DESCRIPTION

FIGS. 1-10 illustrate an embodiment of a prescription bottle cap 10 thatcan dispense a precise dosage of a substance, and that may be used witha conventional prescription pill dispensing bottle. For the sake ofsimplicity, the prescription bottle cap may also be referred to hereinas a “cap 10” and the conventional prescription pill dispensing bottlemay also be referred to herein as a “prescription bottle 80.”

The cap 10 includes a base 20 and a delivery element 30 atop the base20. As depicted by FIGS. 1-10, the base 20 of the cap 10 may have aconfiguration that enables the base 20 to be secured directly to aprescription bottle 80. In such an embodiment, the base 20 may include atop 22 with an outer wall 24 protruding downward from an outer peripheryof the top 22. As shown in FIGS. 7 and 10, an inner surface 26 of theouter wall 24 of the base 20 defines the lateral extent of a receptacle28 capable of receiving an upper portion (not shown) of an outer wall(not shown) of the prescription bottle 80, and bottle coupling features(not shown) on the inner surface 26 of the outer wall 24 of the base 20.The bottle coupling features are complementary to and capable ofengaging corresponding cap coupling features (not shown) at the upperportion of the prescription bottle 80 to enable the cap 10 to be securedto the prescription bottle 80. The bottle coupling features of the cap10 and the cap coupling features of the prescription bottle 80 may haveany suitable configurations known in the art. In a specific embodiment,the cap 10 may comprise a conventional child-resistant prescriptionbottle cap.

Alternatively, the base 20 of the cap 10 may have a configuration thatenables it to be attached to a conventional cap for a prescriptionbottle 80. As an example, the outer wall 24 of the base 20 may define areceptacle 28 that is capable of receiving and engaging a conventionalcap (not shown) for a prescription bottle 80 (e.g., mechanically (e.g.,by way of a snap fit, a press fit, a threaded engagement, etc.),adhesively, etc.).

The delivery element 30 is capable of delivering, or administering, asubstance to an individual. In some embodiments, such as that depictedby FIGS. 1-10, the delivery element 30 of the cap 10 may be capable ofnasal delivery, or administration, of a substance to an individual.

With continued reference to FIGS. 1-10, the delivery element 30 of thecap 10 may include a delivery element housing 31 that is secured to thetop 22 of the base 20 of the cap 10. The delivery element housing 31 mayinclude a top 31T with an outer wall 31 w protruding downward from anouter periphery of the top 31T. As depicted by FIGS. 1-6, 8, and 9,apertures or other receptacles 31R in an interior surface (not shown) ofthe outer wall 31 w of the delivery element housing 31 may receivecomplementary engagement elements 25 that include features that protruderadially outward above the top 22 of the base 20 to enable the deliveryelement housing 31 to mechanically engage the base 20.

As best illustrated by FIGS. 9 and 10, the delivery element housing 31may carry a remainder of the delivery element 30. A trigger receptacle32 may open to the top 31T of the delivery element housing 31 and to arear portion of the outer wall 31 w of the delivery element housing 31,while a nozzle receptacle 33 may comprise an opening in a front portionof the outer wall 31 w of the delivery element housing 31, and extendinto the top 31T of the delivery element housing 31.

With reference to FIGS. 9, 9A, 9B, 9C, and 10, the remainder of thedelivery element 30 includes a trigger 34, a spring housing 40, acompression spring 44, a piston 45, a piston housing 50, an ampoule 58,a needle 65, a needle housing 69, and a nozzle 74.

The spring housing 40 is positioned within the delivery element housing31, just below the trigger receptacle 32. An upper portion of the springhousing 40 is exposed to and is accessible from the trigger receptacle32. A body 41 of the spring housing 40 may be coupled to an interiorportion of the outer wall 31 w of the delivery element housing 31 in amanner that fixes the spring housing 40 securely in place within thedelivery element housing 31, below the trigger receptacle 32. Pivot pins42 that protrude from opposite sides of the body 41 of the springhousing 40 are aligned with each other and may also be accessiblethrough the trigger receptacle 32.

The trigger 34 has a configuration that enables it to be positioned overand to receive an upper portion of the spring housing 40. Asillustrated, the trigger 34 may include a pair of side walls 35 that arespaced apart from one another a sufficient distance that the trigger 34can receive upper portions of the spring housing 40 and the pistonhousing 50. A pivot pin receptacle 36 is recessed in a bottom edge 35Eof each side wall 35 of the trigger 34. Each pivot pin receptacle 36 hasa configuration that enables it to receive and engage a pivot pin 42 ofthe spring housing 40 in a manner that secures the trigger 34 atop thespring housing 40 and that enables the trigger 34 to pivot relative tothe spring housing 40.

In addition, a catch 37 is recessed in the bottom edge 35E of each sidewall 35 of the trigger 34, near a front edge 35F of that side wall 35.The catches 37 may be aligned with one another. The catches 37 may holdthe piston 45 of the delivery element 30 in a cocked position, as willbecome apparent from the description that follows. Bottom portions ofthe front edges 35F of the side walls 35 may taper from the front of thetrigger 34 toward the rear of the trigger 34, or inwardly, to enable thepiston 45 of the delivery element 30 to be reset, or re-cocked, whilethe trigger 34 is depressed, as will become apparent from thedescription that follows.

When the trigger 34 is assembled with the spring housing 40, the trigger34 may protrude through the trigger receptacle 32 of the deliveryelement housing 31. A nozzle receptacle 38 in a top surface 34T of thetrigger 34 may have a configuration that enables the nozzle receptacle38 to receive the nozzle 74 of the delivery element 30, when folded overthe trigger 34, as shown in FIGS. 8 and 10, to pivot the trigger 34forward (i.e., the orientation of the trigger 34 that enables the piston45 of the delivery element 30 to be cocked) and to prevent depression ofthe trigger 34.

Returning reference to the spring housing 40, a bore 43 extends into afront end 41F of the body 41 of the spring housing 40. While a front end43F of the bore 43 is open, a rear end (not shown) of the bore 43 ispartially closed (e.g., has a smaller diameter than the front end 43F,is partially blocked, etc.) or completely closed. The bore 43 has ashape and dimensions that enable it to receive the compression spring44, with a rear end 44R of the compression spring 44 abutting the rearend of the bore 43. The compression spring 44 may have a length thatenables it to reside completely within the bore 43 when compressed andprotrude from the open end of the bore 43 when relaxed. The compressionspring 44 may have a configuration that enables it to exert a desiredamount of force when a compressive force on the compression spring 44 isreleased.

The piston 45 of the delivery element 30 is positioned in front of thespring housing 40 and in front of the compression spring 44. The piston45 includes a body 46 with a rear end 47 that abuts a front end 44F ofthe compression spring 44. A pair of guides 48 protrude from oppositesides of the body 46, and are capable of being engaged by the catches 37in the bottom edges 35E of the side walls 35 of the trigger 34.

A front end 49 of the body 46 of the piston 45 has a configuration thatenables it to abut and apply force to a rear portion of the ampoule 58,which may also be referred to as a “reservoir.”

The piston housing 50 may have a configuration that enables it to guidemovement of the piston 45 as the compression spring 44 forces the piston45 forward. The piston housing 50 may be positioned within the deliveryelement housing 31, with a front portion of the piston housing 50 beingexposed by the nozzle receptacle 32 of the delivery element housing 31.A rear portion of the piston housing 50 may be exposed to the triggerreceptacle 32. A body 51 of the piston housing 50 may be coupled to aninterior of the delivery element housing 31 in a manner that fixes thepiston housing 50 securely in place within the delivery element housing31.

In the embodiment illustrated by FIG. 9, a channel 50 c extends throughan entire length of the body 51 of the piston housing 50. The channel 50c has dimensions that enable it to receive the front end 49 of the body46 of the piston 45. In addition, a horizontally oriented slot 52extends from a rear end 53 of the body 51 to a location near, but shortof, the front end 54 of the body 51. The horizontally oriented slot 52intersects the channel 50 c, enabling the horizontally oriented slot 52to accommodate the guides 48 that protrude from opposite sides of thepiston 45 as the body 46 of the piston 45 is inserted into the channel50 c through the rear end 53 of the body 51. Together, the horizontallyoriented slot 52 and the guides 48 limit forward travel of the piston45, which may prevent damage to the needle 65.

The partial positioning of the rear portion of the piston housing 50below a front portion of the trigger receptacle 32 enables the catches37 in the bottom edges 35E of the side walls 35 of the trigger 34 toengage portions of the guides 48 that protrude from sizes of the body 51of the piston housing 50 when the rear end 47 of the piston 45 is pulledagainst the front end 41F of the spring housing 40 and, thus, while thecompression spring 44 is compressed within the channel bore 43 of thespring housing 40 and the guides 48 are located near a rear end of thehorizontally oriented slot 52.

The front portion of the piston housing 50 includes arms 56. The arms56, which located on opposite sides of the body 51 of the piston housing50, are spaced apart from one another, may comprise extensions of theside walls 51 w of the body 51. More specifically, each arm 56 maycomprise a vertically oriented structure that extends forward beyond thesurface 55 at the front end 54 of the body 51, to which the channel 50 copens, and upward beyond a top surface 51T of the body 51. An upperportion 56 u of each arm 56 may include a pivot point 57, such as anaperture that may receive a pivot pin.

As indicated previously herein, a front portion of the piston housing50, including the front end 54 and front surface 55 of the body 51 ofthe piston housing 50, as well as the arms 56 of the piston housing 50,is exposed through the nozzle receptacle 33 that opens to the front ofthe delivery element housing 31. Thus, when the piston housing 50 isassembled with the delivery element housing 31, the channel 50 c of thepiston housing 50 is exposed through the nozzle receptacle 33. Outersurfaces of the arms 56 may abut side edges of the nozzle receptacle 33,while the upper portion 56 u of each arm 56 may extend beyond a top 31Tof the delivery element housing 31, which may position the pivot point57 of each arm 56 above the top 31T of the delivery element housing 31.

Referring again to the ampoule 58, which is also illustrated by FIG. 9A,a rear end 60 of a body 59 of the ampoule 58 can be removably receivedwithin the channel 50 c of the piston housing 50. A lip 59L may beprovided at the front end 61 of the body 59 to limit a distance theampoule 58 may be inserted into the channel 50 c of the piston 45.

The body 59 of the ampoule 58 defines a reservoir 62, which opens to afront end 61 of the body 59. The reservoir 62 is capable of receivingand containing a single of a drug or another substance. The drug orother substance may be in liquid form (e.g., naloxone, etc.) A stopper64 may be positioned within a front end 62F of the reservoir 62 holdsthat substance within the reservoir 62. The stopper 64 may have aconfiguration that enables it to provide access to the contents of thereservoir 62 when the stopper 64 is subjected to a sufficient force(e.g., that provided by the compression spring 44 and the piston 45,etc.). As an example, the stopper 64 of the ampoule 58 may have aconfiguration (e.g., a shape, dimensions, a material, etc.) that enablesit to be pierced by a needle 65, such as that shown in FIG. 9B, when thecompression spring 44 and the piston 45 force the stopper 64 against apiercing end 65F of the needle 65. In addition, a configuration of thestopper 64 may enable it to be forced rearwardly into the reservoir 62to enable a precise dose of the contents of the reservoir 62 to beforced into a lumen 66 of the needle 65 (and, thus, to be administeredto an individual). Such rearward movement of the stopper 64 through thereservoir 62 may cause all of the contents of the reservoir 62 to beejected through the lumen 66 of the needle 65. By way of example only,the stopper 64 may be formed from an elastomer that may be pierced bythe needle 65 and forced rearwardly through the reservoir 62 by aportion of the needle housing 69 while providing a seal against theinterior surfaces of the reservoir 62.

The substance within the reservoir 62 of the body 59 of the ampoule 58may correspond to a drug within the prescription bottle 80 with whichthe cap 10 is to be used. In some embodiments, the substance maycounteract a potentially negative effect (e.g., an overdose, a sideeffect, etc.) of that drug. As a non-limiting example, when theprescription bottle 80 contains an opioid, the substance within thereservoir 62 of the body 59 of the ampoule 58 may counteract an overdoseof the opioid. More specifically, the substance may comprise thenarcotic counteragent naloxone. In other embodiments, the substancewithin the reservoir 62 of the body 59 of the ampoule 58 may complementor act synergistically with the drug contained by the prescriptionbottle 80 with which the cap 10 is to be used.

The cap 10 may be provided with a plurality of ampoules 58. When the cap10 is used with a prescription bottle 80 that contains a prescriptionfor an opioid, it may be provide with two ampoules 58, each containingan emergency dose of naloxone.

A front end 65F and a portion of the length of the needle 65 may beretained by the needle housing 69, an embodiment of which is depicted byFIGS. 9 and 9C, with the piercing end 65 p of the needle 65 protrudingbeyond a rear end 71 of a body 70 of the needle housing 69. Morespecifically, a lumen 73 through the body 70 may receive a front portionof the needle 65. An orifice 73 o at a front end of the lumen 73, whichopens to a front end 72 of the body 70, may be constricted to limitforward movement of the needle 65 relative to the needle housing 69. Theorifice 73 o may be configured to atomize a substance (e.g., thecontents of the reservoir 62 of the ampoule 58, etc.) as the substanceis forced out of the lumen 66 (FIG. 9B) of the needle 65 and through theorifice 73 o.

The body 70 of the needle housing 69 may have a configuration thatenables it to be received by a receptacle (not shown) that opens to arear end 76 of a body 75 of the nozzle 74. The receptacle in the rearend 76 of the body 75 of the nozzle 74 may also have a configurationthat enables it to receive the front end 61 of the body 59 of theampoule 58 as the piston 45 forces the ampoule 58 forward onto theneedle 65.

The body 75 of the nozzle 74 may be tapered to facilitate is insertioninto a nostril of an individual to whom a dose of the contents of theampoule 58 are to be administered. An orifice 79 in a tip 78 of the body75 communicates with the orifice 73 o of the needle housing 69; thus, asubstance that is ejected through the orifice 73 o of the needle housing69 may pass through the orifice 79 in the tip 78 of the body 75 of thenozzle 74.

At its rear end 76, the body 75 of the nozzle 74 may include a hingeelement 75H, which may extend somewhat upwardly and/or rearwardly fromthe rear end 76 of the body 75. A configuration of the hinge element 75Hmay enable it to be positioned between the arms 56 of the piston housing50. A pivot point 77 of the hinge element 75H may align with the pivotpoints 57 of the arms 56 in a manner that enables the nozzle 74 to bepivotally coupled to the piston housing 50 (e.g., with a pivot pin thatextends through the aligned pivot points 57 and 77, etc.).

The pivotal relationship between the nozzle 74 and the piston housing 50and, thus, between the nozzle 74 and the remainder of the cap 10 enablesmovement of the nozzle 74 between a stored orientation, in which thenozzle 74 is positioned over the trigger 34 (as depicted by FIGS. 8 and10) and a deployed orientation, in which the nozzle 74 may protrude froma remainder of the cap 10 (as depicted by FIGS. 1-7) and can communicatewith an ampoule 58 that has been inserted into the channel 50 c of thepiston housing 50. In the depicted embodiment, the nozzle 74 pivotsabout 180° between its stored orientation and its deployed orientation.

When the nozzle 74 is in its stored orientation, it may partially restwithin the nozzle receptacle 33 of the trigger and may preclude accessto and/or prevent depression of the trigger 34. When the nozzle 74 is inits deployed orientation, the rear end 76 of its body 75, the rear end71 of the body 70 of the needle housing 69, and the piercing end 65 p ofthe needle 65 may be positioned adjacent to or against the front end 54of the body 51 of the piston housing 50 and against the front end 61 ofthe body 59 of an ampoule 58 (if any) disposed within the channel 50 cthrough the piston housing 50. In addition, when the nozzle 74 is in itsdeployed orientation, the nozzle 74 may protrude from the remainder ofthe cap 10 in a manner that facilitates its intended use. For example,the tip 78 of the illustrated embodiment of nozzle 74 may be insertedinto an individual's nostril to enable a substance within the reservoir62 in the body 59 of the ampoule 58 to be forced directly into theindividual's nasal cavity. As will be appreciated, the nozzle 74 may beprovided in one or more sizes (e.g., infant, child, adult, etc.),depending upon the age of the intended recipient and/or the size of theintended recipient's nostrils.

The base 20, the delivery element housing 31, the spring housing 40, thepiston 45, the piston housing 50, and the nozzle 74 may be formed fromany suitable material. As an example, polyethylene terephthalate PET(E),a recyclable and durable material, may be used to form any or all ofthese components. Each of these elements may be formed from anytechnique suitable for use with the desired material (e.g., by injectionmolding processes, etc.).

When the contents of an ampoule 58 are needed, an individual who will beadministering those contents place the nozzle 74 of a delivery element30 of a cap 10 in a stored orientation over the trigger 34 of thedelivery element 30, hold the trigger 34 down, ensure that the ampoule58 is properly oriented, and push the properly oriented ampoule 58 intothe channel 50 c of the piston housing 50. As the ampoule 58 is pushedinto the channel 50 c, it forces the piston 45 back, compressing thecompression spring 44 and enabling the guides 48 that protrude from thebody 46 of the piston 45 to be engaged by the catches 37 in the bottomedges 35E of the side walls 35 of the trigger 34; thus cocking, orloading, the delivery element 30.

With continued reference to FIGS. 9 and 10, the contents of the ampoule58 may be administered by pivoting the nozzle 74 to its deployedorientation, as depicted by FIGS. 8 and 10. With the nozzle 74 in itsdeployed orientation, the trigger 34 is accessible. Once the nozzle 74has been positioned to deliver the contents of the ampoule 58 (e.g., ina nostril of an individual, etc.), the trigger 34 may be pushed, ordepressed. As the trigger 34 is depressed, the catches 37 release theguides 48 of the piston 45, enabling the compression spring 44 to forcethe piston 45 forward through the piston housing 50. As the piston 45moves forward through the piston housing 50, it forces the ampoule 58forward onto the piercing end 65 p of the needle 65. The needle 65 and,optionally, a protruding feature of the needle housing 69 hold thestopper 64 in place, causing it to travel further into the reservoir 62in the body 59 of the ampoule 58 as the ampoule 58 is forced forward. Asthe stopper 64 is forced further into the reservoir 62, its contents areexpelled through the lumen 66 of the needle 65, the orifice 73 o of theneedle housing 69, and out of the orifice 79 in the tip 78 of the nozzle74.

Once a dose of the contents of the ampoule 58 have been administered,the depleted, or spent, ampoule 58 may be removed from the deliveryelement 30, another ampoule 58 may be assembled with the deliveryelement 30, and the delivery element 30 may be reset, or re-cocked. Thenozzle 74 may be placed in its stored orientation over the trigger 34 toenable a depleted ampoule 58 to be removed from the channel 50 c of thepiston housing 50 and to enable an ampoule 58 that contains a dose ofthe substance to be placed into the channel 50 c. The delivery element30 may then be reset in the manner described above. Once the deliveryelement 30 has been reset, the second dosage of the substance may bedelivered to the subject (e.g., into the individual's other nostril whenadministering a substance in an attempt to counteract the effects of anopioid, etc.).

When the cap 10 and its contents (or, more specifically, the contents ofan ampoule 58 that has been assembled with the cap 10) are used tocounteract an opioid overdose by an individual, a person administeringthe contents of the cap 10 should call emergency services (e.g., 911 inthe United States of America, etc.) before administering the contents ofthe cap 10. The number of doses of counteragent that have beenadministered to the affected individual should be reported to theemergency responder.

Another embodiment of a prescription bottle cap 110, which may deliverless precise amounts of a substance than the above-described cap 10, isillustrated by FIGS. 11-20. Such a prescription bottle cap 110 may beuseful in situations where precise dosages are not critical. Theprescription bottle cap 110 may also be referred to as a “cap” 110 forthe sake of simplicity. Like the above-described cap 10, the cap 110 maybe capable of attachment to a conventional prescription pill dispensingbottle 80, which is also referred to as a “prescription bottle” 80 forthe sake of simplicity.

The cap 110 includes a base 120 and a delivery element 130 atop the base120. In some embodiments, the base 120 of the cap 110 may have aconfiguration that enables it to be secured directly to a prescriptionbottle 80. In such an embodiment, the base 120 may include a top 122with an outer wall 124 protruding downward from an outer periphery ofthe top 122. As shown in FIGS. 17 and 20, an inner surface 126 of theouter wall 124 of the base 120 defines the lateral extent of areceptacle 128 capable of receiving an upper portion 82 of an outer wall84 of the prescription bottle 80, and bottle coupling features 127 onthe inner surface 126 of the outer wall 124 of the base 120. The bottlecoupling features 127 are complementary to and capable of engagingcorresponding cap coupling features 87 at the upper portion 82 of theprescription bottle 80 to enable the cap 110 to be secured to theprescription bottle 80. The bottle coupling features 127 of the cap 110and the cap coupling features 87 of the prescription bottle 80 may haveany suitable configurations known in the art. In a specific embodiment,the cap 110 may comprise a conventional child-resistant prescriptionbottle cap.

Alternatively, the base 120 of the cap 110 may have a configuration thatenables it to be attached to a conventional cap for a prescriptionbottle. As an example, the outer wall 124 of the base 120 may define areceptacle 128 that is capable of receiving and engaging a conventionalcap 90 for a prescription bottle 80 (e.g., mechanically (e.g., by way ofa snap fit, a press fit, a threaded engagement, etc.), adhesively,etc.).

With continued reference to FIGS. 11-20, the delivery element 130 of thecap 110 is capable of delivering, or administering, a substance to anindividual. In some embodiments, such as that depicted by FIGS. 11-20,the delivery element 130 of the cap 110 may be capable of nasaldelivery, or administration, of a substance to an individual.

The delivery element 130 of the embodiment of cap 110 depicted by FIGS.11-20 includes an annular member 132 that protrudes upwardly from thetop 122 of the base 120 of the cap 110. As best illustrated by FIGS. 19and 20, inner surfaces 134 of the annular member 132 and an uppersurface of the top 122 of the base 120 may define a receptacle 136 foran atomizer bulb 150 of the delivery element 130.

The atomizer bulb 150 may be configured in a manner known to those ofordinary skill in the art. The atomizer bulb 150 may include a body 152that comprises a compressible, resilient structure (e.g., it may beformed from a medical grade rubber, etc.). In general, an interior ofthe body of the atomizer bulb 150 may comprise a reservoir (not shown)capable of receiving and holding a substance (not shown) for potentialadministration to an individual. As shown in FIG. 19, the atomizer bulb150 includes an outlet 158 that may communicate with the reservoir,enabling introduction of the substance into the reservoir defined withinthe body 152 of the atomizer bulb 150 and enabling ejection of thesubstance from the reservoir. The outlet 158 may protrude from a body152 of the atomizer bulb 150.

A top of the atomizer bulb 150 may serve as an actuator 156 that iscapable of causing a substance within the reservoir of the body 152 ofthe atomizer bulb 150 to be forced from the reservoir and out of theoutlet 158. More specifically, as the actuator 156 of the atomizer bulb150 is depressed, a volume within the reservoir may decrease, increasingan air pressure within the reservoir and mixing a substance within thereservoir with air and forcing the mixture out of the reservoir throughthe outlet 158. The atomizer bulb 150 may deliver an approximate dose ofthe substance when the actuator 156 is depressed.

A base 154 of the body 152 of the atomizer bulb 150 may have aconfiguration that enables it to seat properly within the receptacle 136within the annular member 132 of the delivery element 130 of the cap 110(e.g. the base 154 of the body 152 of the atomizer bulb 150 may besubstantially flat, flat, shaped complementarily to a shape of the top122 of the base 120 of the cap 110, etc.). The body 152 of the atomizerbulb 150 may resiliently engage the inner surfaces 134 of the annularmember 132 to removably secure the atomizer bulb 150 within thereceptacle 136. Alternatively, or in addition, the base 154 of the body152 of the atomizer bulb 150 may be affixed within the receptacle 136with an adhesive material. Without limitation, a removable, pressuresensitive adhesive material may facilitate removal of the atomizer bulb150 from the receptacle 136 to enable replenishment of the substancewithin the reservoir of the atomizer bulb 150 after it has been used oronce it has reached its expiration date.

The annular member 132 and/or a shape of the atomizer bulb 150 may becapable of ensuring that the atomizer bulb 150 is properly alignedwithin the receptacle 136 defined by the annular member 132. In thedepicted embodiment, the annular member 132 may receive the atomizerbulb 150 in such a way that an outlet 158 of the atomizer bulb 150extends into a slot 138 defined through a portion of the annular member132.

The open top of the annular member 132 of the delivery element 130 ofthe cap 110 enables the atomizer bulb 150 to be assembled with the cap110, and provides access to the actuator 156 of the atomizer bulb 150.The annular member 132 may taper downward from front to back to furtherfacilitate operation of the actuator 156 with an individual's finger orthumb. While the annular member 132 provides access to the actuator 156,its configuration—it may substantially surround the atomizer bulb150—and height may prevent inadvertent depression of the actuator 156and, thus, inadvertent dispensing of substance within the reservoir ofthe body 152 of the atomizer bulb 150.

In addition to being able to receive the outlet 158 of the atomizer bulb150 of the delivery element 130 of the cap 110, the slot 138 in theannular member 132 of the delivery element 130 may be capable oforienting a nozzle 160 of the delivery element 130 in such a way thatthe nozzle 160 can receive and convey a substance ejected by the outlet158 of the atomizer bulb 150. In addition, the slot 138 may have aconfiguration that enables it to receive and engage a portion of thenozzle 160. More specifically, the slot 138 may include a pair ofopposed end walls 140. Each end wall 140 may include a pivot element145. In the depicted embodiment, each pivot element 145 comprises acylindrical protrusion, with pair of pivot elements 145 being opposed toand protruding toward one another. In addition, at least one end wall140 may include a retention feature 146 that may hold the nozzle 160 inone or more orientations. As depicted, each retention feature 146 maycomprise an elongated protrusion.

The pivot elements 145 of the end walls 140 of the slot 138 in theannular member 132 of the delivery element 130 of the cap 110 may engageor be engaged by complementary pivot elements 165 of the nozzle 160.More specifically, the nozzle 160 may include a pair of attachment arms164 that protrude from opposite sides of a rear end 161 of the nozzle160. The attachment arms 164 may be spaced apart a sufficient distanceto receive the outlet 158 of the atomizer bulb 150. Each attachment arm164 may include a pivot element 165. In the depicted embodiment, eachpivot element 165 comprises a circular aperture that extends through itscorresponding attachment arm 164 to receive a cylindrical pivot element145 that protrudes from a corresponding end wall 140 of the slot 138.When assembled, the pivot elements 145 of the annular member 132 and thepivot elements 165 of the attachment arms 164 of the nozzle 160 functiontogether to enable the nozzle 160 to pivot relative to the annularmember 132 of the cap 110 and relative to any atomizer bulb 150 withinthe receptacle 136 defined by the annular member 132.

In addition to including a pivot element 165, at least one attachmentarm 164 may include a retention feature 166 at its outer surface. Theretention feature 166 may be configured complementarily to and be ableto engage a corresponding retention feature 146 of an end wall 140 ofthe annular member 132 that defines a side of the slot 138 through theannular member 132. In the depicted embodiment, each retention feature166 comprises an elongated recess in the outer surface of its attachmentarm 164; the elongated recess is capable of receiving the elongatedprotrusion that forms the corresponding retention feature 146 on thecorresponding end wall 140. Such engagement may hold, or retain, thenozzle 160 in one or more orientations.

The pivotal relationship between the nozzle 160 and the remainder of thecap 110 enables movement of the nozzle 160 between a stored orientation,in which the nozzle 160 is positioned over the actuator 156 of theatomizer bulb 150 (as depicted by FIGS. 18 and 20) and a deployedorientation, in which the nozzle 160 can communicate with the outlet 158of the atomizer bulb 150 and may protrude from a remainder of the cap110 (as depicted by FIGS. 11-17). In the depicted embodiment, the nozzle160 pivots about 180° between its stored orientation and its deployedorientation.

The relative arrangements of the retention feature(s) 146 on the endwall(s) 140 of the annular member 132 and the retention feature(s) 166of the corresponding attachment arm(s) 164 of the nozzle 160 may engageeach other to hold the nozzle 160 into place into one or both of thestored orientation and the deployed orientation. The correspondingretention feature(s) 146 and retention feature(s) 166 may be disengaged,and the nozzle 160 pivoted, upon application of a sufficient pivotingforce to the nozzle 160 to disengage the corresponding retentionfeature(s) 146 and retention feature(s) 166.

When the nozzle 160 is in its stored orientation, it may preclude accessto and/or prevent depression of the actuator 156 of the atomizer bulb150. When the nozzle 160 is in its deployed orientation, its rear end161 may be positioned adjacent to or against an end of the outlet 158 ofthe atomizer bulb 150, and a channel 163 through the nozzle 160 may bealigned with an aperture 159 of the outlet 158. As can be best seen inFIG. 18, the rear end 161 of the nozzle 160 may be recessed, enabling itto receive an end of the outlet 158 of the atomizer bulb 150 in a mannerthat ensures alignment of the channel 163 of the nozzle 160 with theaperture 159 of the outlet 158. In some embodiments, the rear end 161 ofthe nozzle 160 and/or the end of the outlet 158 may be formed from acompressible resilient material or provided with a sealing element(e.g., an O-ring, etc.) to seal the joint between the aperture 159 ofthe outlet 158 and the channel 163 of the nozzle 160. In addition, whenthe nozzle 160 is in its deployed orientation, the nozzle 160 mayprotrude from the remainder of the cap 110 in a manner that facilitatesits intended use. For example, a tip 162 of the illustrated embodimentof nozzle 160 may be inserted into an individuals' nostril to enable asubstance within the reservoir in the body 152 of the atomizer bulb 150to be forced directly into the individual's nasal cavity. As will beappreciated, the nozzle 160 may be provided in one or more sizes (e.g.,infant, child, adult, etc.), depending upon the age of the intendedrecipient and/or the size of the intended recipient's nostrils.

As shown in FIG. 19, a safety cap 170 may be provided with the cap 110to limit access to the delivery element 130 until the delivery element130 is needed. The safety cap 170 may comprise a conventional snap-oncap that engages features on an outer surface of the annular member 132.A bottom edge of the safety cap 170 may rest on or adjacent to a portionof the top 122 of the base 120 that is exposed beyond an outer peripheryof the annular member 132. The safety cap 170 may provide a protectivecovering for the delivery element 130 of the cap 110 and the substancethat within the reservoir within the body 152 of the atomizer bulb 150of the delivery element 130. A removable seal may secure the safety cap170 to the remainder of the cap 110.

The base 120, the annular member 132, the nozzle 160, and the safety cap170 may be formed from any suitable material. As an example,polyethylene terephthalate PET(E), a recyclable and durable material,may be used to form any or all of these components. Each of theseelements may be formed from any technique suitable for use with thedesired material (e.g., by injection molding processes, etc.).

In some embodiments, the cap 110 may be provided in a sealed wrapper.

In use, the cap 110 may be removed from its prescription bottle 80 (ifthe cap 110 has not already been removed), a safety cap 170 may beremoved from the cap 110 (if the safety cap 170 is assembled with thecap 110), and the nozzle 160 may be pivoted to its deployed orientation.With the nozzle 160 in its deployed orientation, it may be inserted intoone of an individual's nostrils. The actuator 156 may then be pressedfirmly to force the substance within the reservoir of the body 152 ofthe atomizer bulb 150 through the nozzle 160 and into the individual'snasal cavity. Once the counteragent has been administered, the nozzle160 may be removed from the affected individual's nostril. A second doseof the substance may be administered to the individual by replacing thedepleted, or spent, atomizer bulb 150 with a fresh atomizer bulb 150,reinserting the nozzle 160 into the individual's other nostril andfirmly pressing the actuator 156 of the fresh atomizer bulb 150.

Although the foregoing description sets forth many specifics, theseshould not be construed as limiting the scope of any of the claims, butmerely as providing illustrations of some embodiments and variations ofelements or features of the disclosed subject matter. Other embodimentsof the disclosed subject matter may be devised which do not depart fromthe spirit or scope of any of the claims. Features from differentembodiments may be employed in combination. Accordingly, the scope ofeach claim is limited only by its plain language and the legalequivalents thereto.

What is claimed:
 1. A cap for a prescription bottle, comprising: a basesecurable to a top of a prescription bottle to confine contents of theprescription bottle within an interior of the prescription bottle; and adelivery element carried by the base and including: a reservoir thatcontains a substance; a nozzle in fluid communication with thereservoir, the nozzle moveable between: a stored orientation; and adeployed orientation; and an actuator that forces the substance from thereservoir, through the nozzle, and out of the nozzle, the actuatorincluding a receptacle for the nozzle that receives the nozzle in thestored orientation to prevent actuation of the actuator, the actuatoraccessible with the nozzle in the deployed orientation.
 2. The cap ofclaim 1, wherein the delivery element is assembled with the base.
 3. Thecap of claim 2, wherein the delivery element is removable from the base.4. The cap of claim 1, wherein the delivery element is integral with thebase.
 5. The cap of claim 1, wherein the substance comprises an opioidoverdose reversal agent.
 6. The cap of claim 5, wherein the opioidoverdose reversal agent comprises naloxone.
 7. The cap of claim 1,wherein the substance comprises a nasally deliverable drug.
 8. The capof claim 1, wherein the nozzle, while in the stored orientation,prevents depression of the actuator.
 9. The cap of claim 1, wherein thenozzle, while in the deployed orientation, protrudes from the deliveryelement.
 10. The cap of claim 9, wherein the nozzle, while in thedeployed orientation, protrudes beyond an outer peripheral edge of thedelivery element.
 11. A drug delivery system, comprising: a prescriptionbottle; and a cap, including: a base that couples to the prescriptionbottle over an opening of the prescription bottle; and a deliveryelement carried by the base and including: a reservoir that receives asubstance; a nozzle movable between a stored orientation and a deployedorientation; and a trigger that forces the substance from the reservoirthrough the nozzle, the trigger including a recess that receives thenozzle in the stored orientation to prevent depression of the trigger,the trigger exposed and depressible with the nozzle in the deployedorientation.
 12. The drug delivery system of claim 11, wherein thenozzle is compactly associated with a remainder of the delivery elementin the stored orientation and protrudes from a remainder of the deliveryelement in the deployed orientation.
 13. The drug delivery system ofclaim 11, wherein the delivery element of the cap further includes: aspring; a piston having a loaded position in which the trigger preventsa force of the spring from acting on the piston and a released positionin which force of the spring has moved the piston; and a piston housingincluding a channel with a rear end that receives the piston and a frontend that receives an ampoule comprising the reservoir, the nozzlepositioning a tip of a needle adjacent to a front end of the ampoule toenable the tip of the needle to puncture a stopper of the ampoule and tohold the stopper in place as the piston is driven forward by the forceof the spring and drives a body of the ampoule forward, the needlereceiving and conveying the substance to an orifice of the nozzle. 14.The drug delivery system of claim 13, wherein the ampoule contains apremeasured dose of a drug.
 15. The drug delivery system of claim 14,wherein the orifice of the nozzle comprises an atomizer.
 16. The drugdelivery system of claim 11, wherein the prescription bottle contains anopioid and the reservoir receives an opioid overdose reversal agent. 17.A method for providing a substance to an individual, comprising: fillinga bottle with the substance; and securing a cap to the bottle to securethe substance within the bottle, the cap containing an another substanceand being capable of readily administering the another substance to theindividual, the cap including an actuator and a nozzle, the nozzlemovable between a stored orientation and a deployed orientation, theactuator including a receptacle that receives the nozzle in the storedorientation to prevent actuation of the actuator, the actuator exposedand depressible with the nozzle in the deployed orientation.
 18. Themethod of claim 17, wherein securing the cap to the bottle comprisessecuring a cap with a nozzle and a pump for nasally administering theanother substance to the individual to the bottle.
 19. The method ofclaim 17, wherein filling the bottle with the substance comprisesfilling the bottle with a prescription drug, as prescribed by a licensedmedical professional.
 20. The method of claim 19, wherein: filling thebottle with the substance comprises filling the bottle with an opioid;and securing the cap to the bottle comprises securing the cap with theanother substance comprising an opioid reversal agent to the bottle.